A Phase 3 interventional study of Barzolvolimab and Matching Placebo in Chronic Inducible Urticaria, Cold Urticaria and Cold-Induced Urticaria, sponsored by Celldex Therapeutics. Recruiting at 72 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Celldex Therapeutics · Phase 3, Interventional, and Treatment
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria (ColdU) or symptomatic dermographism (SD) who remain symptomatic despite the use of H1-antihistamines.
There is a Screening Period of up to 4 weeks, followed by a 24-week treatment period where patients will receive barzolvolimab or placebo. Patients receiving barzolvolimab will receive 450mg at the start of the treatment period and then 150mg every 4 weeks. Then there is a 28-week treatment period where all patients will receive 300mg barzolvolimab every 8 weeks, followed by a 16-week follow-up period where all patients are observed.
Celldex Therapeutics is the lead sponsor of 45 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
Key Exclusion Criteria:
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Barzolvolimab
Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Matching Placebo
barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Barzolvolimab
Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Matching Placebo
Subcutaneous Administration
Also known as: CDX-0159
Subcutaneous Administration
Complete response to provocation testing at Week 12
Proportion of Cold Induced Urticaria \[ColdU\] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism \[SD\] participants with complete response in Critical Friction Threshold at Week 12. * For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a complete response test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
Time frame: From Day 1 (first dose) to Week 12
Complete response to provocation testing at Week 24 for Cold Induced Urticaria participants
Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
Time frame: From Day 1 (first dose) to Week 24
Complete response to provocation testing at Week 24 for Symptomatic Dermographism
Proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 24. Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
Time frame: From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of itch at Week 12
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Time frame: From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of itch at Week 24
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Time frame: From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of itch following provocation testing (WI-NRSprovo) at Week 12
Change from baseline in WI-NRSprovo at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Time frame: From Day 1 (first dose) to Week 12
Complete response to provocation testing at Week 4
Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 4 or proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 4
Time frame: From Day 1 (first dose) to Week 4
Improvement in clinical symptoms of hives at Week 12
Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Time frame: From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of hives at Week 24
Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Time frame: From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 12
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 12. CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark.
Time frame: From Day 1 (first dose) to Week 12
Change from baseline in Critical Friction Threshold (CFT) at Week 12
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 12. CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark.
Time frame: From Day 1 (first dose) to Week 12
Change from baseline in Critical Temperature Threshold (CTT) at Week 24
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 24.
Time frame: From Day 1 (first dose) to Week 24
Change from baseline in Critical Friction Threshold (CFT) at Week 24
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 24.
Time frame: From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 4
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 4.
Time frame: From Day 1 (first dose) to Week 4
Change from baseline in Critical Friction Threshold (CFT) at Week 4
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 4.
Time frame: From Day 1 (first dose) to Week 4
Improvement in Dermatology Quality of Life Index (DLQI) at Week 12
Proportion of participants with DLQI = 0-1 at Week 12.
Time frame: From Day 1 (first dose) to Week 12
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Barzolvolimab
Chronic Inducible Urticaria